MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER BIZACT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	BZ4212A
Medical Device Problem Code	Energy Output Problem (1431)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	08/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, three days after tonsillectomy, the device had inadequately sealed the inferior pole of left tonsil bed.Reoperation was initiated to coagulate the tonsil bed.The patient had 1000 cubic centimeters (cc) of blood loss.Blood transfusion was not required.The patient was sent home stable with no active bleeding.

• Brand Name: BIZACT
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 9090446
• Report Number: 1717344-2019-01193
• Device Sequence Number: 19407585
• Product Code: GEI
• UDI-Device Identifier: 10884521723016
• UDI-Public: 10884521723016
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K171066
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/13/2022
• Device Model Number: BZ4212A
• Device Catalogue Number: BZ4212A
• Device Lot Number: 72400183X
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR
• Patient Weight: 108